Anthony has almost two decades of experience in commissioning, qualification, validation and CGMP compliance within the pharmaceutical and biotech industries. He has experience in the preparation and execution of commissioning, installation qualification, operational qualification, and performance qualification protocols for many types of equipment, systems and utilities; including implementation of various levels of integrated C&Q approaches and delivery based on leveraging of documentation and testing.
Anthony has managed numerous large C&Q projects for pharmaceutical, biotech, and medical device facilities working effectively with cross-functional teams. Areas of expertise include project master planning, risk/impact assessments, cleanroom facilities, utility systems, environmental monitoring, CFR 21 Part 11 issues, Kaye Validator/ValProbe mapping, generation of project support documentation such as change controls and standard operating procedures (SOPs), and generation of validation life cycle documentation from user requirements specifications through validation activities.
- B.S. - Chemical Engineering, Pennsylvania State University
- International Society for Pharmaceutical Engineering (ISPE)